Inshamake ya Politiki |Itangazo ryubuyobozi bwa leta bushinzwe ibiyobyabwenge ku bijyanye no guhindura igice cya Cataloge y’ibikoresho by’ubuvuzi

Mu rwego rwo kurushaho kunoza ivugurura rya sisitemu yo gusuzuma no kwemeza ibikoresho by’ubuvuzi, hashingiwe ku iterambere ry’inganda zikoreshwa mu buvuzi no kugenzura no gucunga neza ibikoresho by’ubuvuzi, hakurikijwe “Amabwiriza agenga kugenzura no gucunga ibikoresho by’ubuvuzi” .Ibibazo bireba byatangajwe ku buryo bukurikira:

Guhindura ibyiciro 58 byibikoresho byubuvuzi bijyanye nibiri muri "Catalogi ya Medical Device Classification Catalog", ibyahinduwe byihariye birerekanwa kumugereka.

Ibisabwa Gushyira mu bikorwa

. sisitemu ya rotary excision biopsy hamwe nibindi bikoresho "bicungwa nkibikoresho byubuvuzi byo mu cyiciro cya III, guhera umunsi byatangarijweho, ishami rishinzwe imiti rigomba, hakurikijwe" Kwiyandikisha mu bikoresho by’ubuvuzi n’ibikoresho "," urushinge rwo kuzunguruka amabere kandi ibikoresho ”.Sisitemu ya rotary excision biopsy sisitemu nibindi bikoresho "muri" Amabere ya rotary excision puncture inshinge nibindi bikoresho ", kuva umunsi yatangarijweho, ishami rishinzwe kugenzura no gucunga ibiyobyabwenge hakurikijwe" Kwiyandikisha mubikoresho byubuvuzi no gufata ibyemezo "" Ku Itangazo rya Ibisabwa mu iyandikisha ry'ibikoresho by'ubuvuzi n'imiterere y'inyandiko yemewe ”n'ibindi.Amatangazo yerekeye gutangaza ibyangombwa bisabwa kugirango yandike ibikoresho byubuvuzi hamwe nuburyo bwo kwemeza ibyangombwa ", nibindi, ishami rishinzwe imiti rizemera gusaba kwandikisha ibikoresho byubuvuzi ukurikije icyiciro cyahinduwe.

Kuberako itangazo ryakiriwe mbere yo kurangiza icyemezo cyo kwiyandikisha (harimo kwiyandikisha bwa mbere no gukomeza kwiyandikisha) ibikoresho byubuvuzi, ishami rishinzwe kugenzura ibiyobyabwenge n’imicungire y’imiyoborere bikomeje gusuzuma no kwemezwa hakurikijwe iyakirwa ry’icyiciro, kwiyandikisha biratangwa, itangwa ryicyemezo cyo kwandikisha ibikoresho byubuvuzi, bigarukira gusa ku cyemezo cy’iyandikisha ry’ibikoresho by’ubuvuzi ku gihe ntarengwa cyo ku ya 31 Ukuboza 2025, no mu nyandiko y’icyemezo cyo kwiyandikisha inkingi nyuma yo guhindura icyiciro cyo gucunga ibicuruzwa.Kuberako yabonye icyemezo cyo kwiyandikisha mubikoresho byubuvuzi byo mucyiciro cya kabiri, mbere yitariki ya 31 Ukuboza 2025 icyemezo cyo kwandikisha ibicuruzwa gikomeje kuba cyemewe, uwiyandikishije agomba kubigiramo uruhare akurikije ibisabwa bijyanye nicyiciro cy’ubuyobozi kugira ngo akore neza ihinduka ry’iyandikisha. icyemezo, mbere yitariki ya 31 Ukuboza 2025 kugirango barangize guhinduka.Kora imirimo yo guhindura mugihe icyemezo cyambere cyo kwandikisha ibikoresho byubuvuzi kirangiye, mumutekano wibicuruzwa kandi bifite akamaro kandi byashyizwe kurutonde hashingiwe ko nta bintu bibi byabaye cyangwa impanuka nziza, uwiyandikishije ashobora gukurikiza imiterere yubuyobozi bwambere nibyiciro byumwimerere. ishami ryemerera gusaba kongererwa igihe, kongerwa, agaciro kicyemezo cyambere cyo kwandikisha ibikoresho byubuvuzi ntigishobora kurenza 31 Ukuboza 2025.

Kuva ku ya 1 Mutarama 2026, ibyo bicuruzwa ntibishobora gukorwa, gutumizwa mu mahanga no kugurisha bitabonye icyemezo cyo kwiyandikisha ku bikoresho by’ubuvuzi byo mu cyiciro cya III hakurikijwe amategeko.Inganda zibishinzwe zigomba gushyira mubikorwa neza inshingano nyamukuru yubuziranenge bwumutekano n’umutekano kugira ngo umutekano n’ingirakamaro ku bicuruzwa byashyizwe ku rutonde.

. gutangaza amakuru no kwemeza imiterere yinyandiko "" kubyerekeye itangwa ryibikoresho byubuvuzi byo mu cyiciro cya mbere ku itangazwa ry’ibibazo bifitanye isano "n'ibindi, ukurikije icyiciro cyahinduwe kugira ngo wemere gusaba kwandikisha ibikoresho by'ubuvuzi cyangwa Kuri Inyandiko.

Kubyemewe bitararangira kwemererwa kwiyandikisha (harimo kwiyandikisha bwa mbere no kuvugurura iyandikwa) ryibikoresho byubuvuzi, ishami rishinzwe kugenzura ibiyobyabwenge n’imicungire ikomeje gusuzuma no kwemeza hakurikijwe icyiciro cyambere cyo kwemererwa, kwiyandikisha biratangwa, gutanga Icyemezo cyo kwandikisha ibikoresho byubuvuzi, no mubyemezo byiyandikisha byerekana inkingi nyuma yo guhindura icyiciro cyo gucunga ibicuruzwa.

Kubikoresho byubuvuzi byanditse, icyiciro cyacyo cyo kuyobora kuva mucyiciro cya gatatu cyahinduwe kugeza mucyiciro cya kabiri, icyemezo cyo kwandikisha ibikoresho byubuvuzi mugihe cyemewe gikomeje kuba cyemewe.Niba ukeneye gukomeza, uwiyandikishije agomba kuba mubyemezo byubuvuzi byubuvuzi birangira amezi 6 mbere yitariki yo kurangiriraho, ukurikije icyiciro nyuma yo guhindura ishami rishinzwe kugenzura no gucunga ibiyobyabwenge bikwiye kugirango bisabe kongererwa kwiyandikisha, byemewe kuvugururwa. yo kwiyandikisha, ukurikije icyiciro cyahinduwe cyo gucunga ibicuruzwa gitangwa nicyemezo cyo kwandikisha ibikoresho byubuvuzi.

Kubikoresho byubuvuzi byanditswe, icyiciro cyacyo cyo kuyobora kuva mucyiciro cya kabiri cyahinduwe kugeza mucyiciro cya mbere, icyemezo cyo kwandikisha ibikoresho byubuvuzi mugihe cyemewe gikomeje kuba cyemewe.Mbere yuko icyemezo cyo kwiyandikisha kirangira, uwiyandikishije arashobora gusaba ibicuruzwa kubiro bishinzwe.

Icyemezo cyo kwandikisha ibikoresho byubuvuzi bifite ishingiro ryimpinduka zo kwiyandikisha, uwiyandikishije arasaba ishami ryambere ryiyandikisha kugirango ahindure kwiyandikisha.Niba icyemezo cyumwimerere cyo kwiyandikisha gitanzwe hakurikijwe "Cataloge yubuvuzi bwa Catalogi yubuvuzi", iri tangazo ririmo guhindura dosiye yo kwandikisha ibicuruzwa bigomba kwerekanwa kumurongo wamagambo nyuma yo gushyira mubikorwa itangazwa ryicyiciro cyo gucunga ibicuruzwa.

.